Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
TGIC was tested in three independent Dominant-lethal assay. None of them showed significant adverse effects on male reproductive parameters. Although only the males were exposed to TGIC, no adverse reproductive effects are expected as an other diepoxide, Bisphenol-A diglycidyl ether (CAS no. 1675-54-3) caused no reproductive effects in a 2-generation reproduction study in rats. 
Thus, it can be expected that under the conditions of the Regulatory Occupational Exposure Limits (0.05 mg/m3 air) no adverse reproductive effects will occur , neither in rodents nor in man.
Effect on fertility: via oral route
Dose descriptor:
NOAEL
2 mg/kg bw/day
Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
2.5 mg/m³
Additional information

Although the fertility parameters such as mating index, sperm viability, sperm number, pregnancy rate, pup viability, pup number and implantation rate, etc., have been measured only in test with treated males (and not females) it can be concluded that fertility is not affected in male and female animals and man at dose levels below 1 mg/kg (oral and 1 mg/m3 air (inhalation).

With respect to dermal exposure, no studies have been conducted to determine the fertility parameters of TGIC. However, based on the extremely low toxicity of TGIC in the acute dermal toxicity test (as compared to oral or inhalation route), the risk of toxic effects to fertility is minimal. The most relevant route of exposure is inhalation, for which a Occupational Exposure Limit of 0.05 mg/m3 air has been established the European Community.

Thus, under the exposure conditions imposed by Regulatory Authorities no risk on fertility is overt.


Short description of key information:
Male fertility has been affected by TGIC in such a way that total sperm counts were slightly reduced, and sperm motility was reduced, however, overall reproductive performance was not affected, as pregnancy rates were identical to control values at all dose levels tested.
Although female fertility parameters have not been investigated in detail, female reproductive organs of chronically treated females showed no histopathological effects at all dose levels tested.
Comparable epoxides such as bisphenol-A diglycidyl ether (CAS-no. 1675-54-3, showed no effects on female fertility parameters.
In summary, it can be rreasonably assumed that TGIC does not cause adverse effects on fertility , especially below the NOAEL and NOAEC determined in the oral and inhalation studies described.

Effects on developmental toxicity

Description of key information
Information on this endpoint has been waived because effects on reproduction can be omitted for substances classified as a germ cell mutagen cat. 1B (CLP regulation (EC) 1272/2008, if appropriate risk management measures are implemented (column 2 of Annexes IX and X 8.7 of the REACH regulation).  According to REACH regulation, Annex I, Section 6, these conditions are met, if the risk characterisation ratios (RCRs) are all below 1. The RCRs calculated with  the DNELs and PNEC of this substance and exposures estimates derived from  modeling with standard tools are all below 1.0.  Therefore the risk management measures implemented are considered to protect workers and environment.

Justification for classification or non-classification